By Fineline Cube Hansoh Pharmaceutical Group Company Limited (HKG: 3692) announced that its core product, Ameile (almonertinib), has been granted its fifth indication by China’s National Medical Products Administration (NMPA). The drug, in combination with pemetrexed and platinum‑based chemotherapy, is now approved for the first‑line treatment of adult patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | Ameile (almonertinib) |
| Company | Hansoh Pharmaceutical Group (3692.HK) |
| Regulatory Status | Fifth NMPA indication approved |
| New Indication | First‑line treatment of EGFR‑mutated (exon 19/21) locally advanced/metastatic NSCLC |
| Combination | Pemetrexed + platinum‑based chemotherapy |
| Drug Class | Third‑generation EGFR‑TKI |
| Significance | China’s first domestically developed third‑generation EGFR‑TKI |
Product Profile: Ameile (Almonertinib)
Key Characteristics:
- First‑in‑China: First domestically developed third‑generation EGFR‑TKI
- Pharmacokinetics: Excellent lipid solubility and stability
- Blood‑Brain Barrier: Superior penetration for CNS metastases
- Safety: Low incidence of adverse reactions vs. earlier generations
Mechanism: Selectively inhibits EGFR sensitizing mutations (exon 19 deletions, L858R) and T790M resistance mutation.
Previous Indications (All NRDL‑Included)
Ameile has received four prior approvals, all included in the National Reimbursement Drug List (NRDL):
- Adjuvant therapy for post‑operative patients with EGFR‑mutated NSCLC
- Maintenance therapy for unresectable locally advanced NSCLC following chemoradiotherapy
- First‑line treatment for advanced NSCLC (monotherapy)
- Second‑line treatment for advanced NSCLC (post‑first‑line progression)
Market Opportunity: EGFR‑Mutated NSCLC
China Market Context:
- NSCLC Incidence: ~800,000 new cases annually in China
- EGFR Mutation Rate: 30‑40% of NSCLC patients → ~240,000‑320,000 eligible
- First‑Line Setting: Largest segment (60‑70% of eligible patients)
- Market Size: China EGFR‑TKI market ¥45 billion (2025), growing at 8% CAGR
Ameile Revenue Projection:
- 2025: ¥3.5 billion (existing indications)
- 2026 (with 5th indication): ¥5.0‑5.5 billion (US$700‑770 million)
- Peak (2028‑2030): ¥7‑8 billion across all lines
Competitive Landscape
| Drug | Company | Generation | China Status | Key Limitations |
|---|---|---|---|---|
| Ameile | Hansoh | 3rd (domestic) | 5 indications | Broadest label |
| Tagrisso | AstraZeneca | 3rd (imported) | Marketed | Higher cost, limited combos |
| Iressa | AstraZeneca | 1st | Generic | Resistance, CNS penetration |
| Conmana | Betta Pharma | 2nd | Marketed | T790M only |
| Afanix | Boehringer | 2nd | Marketed | Diarrhea risk |
Differentiation: Ameile’s CNS penetration and combination chemo approval provide competitive edge vs. monotherapy‑only competitors.
Combination Strategy Rationale
Chemo + TKI Synergy: Pemetrexed + platinum enhances tumor cell killing and delays resistance, supported by RELAY and NEJ009 trials for similar combos.
Clinical Data: Hansoh’s HSC‑L‑307 trial (not yet published) demonstrated superior PFS vs. chemotherapy alone in EGFR‑mutated NSCLC.
Safety: Ameile’s low toxicity profile enables feasible combination without excessive myelosuppression.
Financial Impact & Valuation
Incremental Revenue: Fifth indication expected to add ¥1.5‑2.0 billion annually by 2027, representing 30‑35% of Ameile’s total sales.
NRDL Benefit: Inclusion in NRDL (achieved for all 4 prior indications) ensures 70‑80% price discount but 3‑4x volume increase, maintaining net revenue growth.
Pipeline Leverage: Success validates Hansoh’s EGFR platform, supporting fourth‑generation TKI (HS‑10296) in Phase I.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Ameile’s market penetration, revenue forecasts, competitive positioning, and pipeline development. Actual results may differ materially due to pricing negotiations, competitive dynamics, regulatory review timelines, and NRDL inclusion decisions.-Fineline Info & Tech